Harm-reduction drug for celiacs shows promising results

On a different note than Wednesday’s alert, today’s post is about promising data on a drug for those of us with celiac disease.

The drug, currently carrying the less-than-sexy moniker ALV003, was designed by Alvine Pharmaceuticals to diminish, “gluten-induced intestinal mucosal injury in well-controlled celiac disease patients.” Phase 2a trials went well, hence this post.
Data from 34 celiac disease patients was included in the study; some patients were given the drug and others a placebo. All ingested 2g of gluten every day for six weeks. The group with the placebo reported higher incidence of “non-serious adverse events” (code for GI symptoms). They also had significantly more mucosal injury in their small intestines, as measured by biopsy data.

How does ALV003 work? The specifics are beyond me, but the basic info is that it breaks the gluten molecule down into nontoxic fragments. You can read more on Alvine’s website, as well as more about their other celiac-related in-process products.

To read the press release about these most recent findings, have a looksee here.

ALV003 will enter Phase 2b trials soon; after that come Phase 3 trials and (hopefully) submission to the FDA for approval.

If your body is sensitive to gluten then why would you continue to feed your body gluten – even if you are taking a pill to break it down – it seems wrong. Your body is telling you something. You should listen to it.

I look forward to the ALV003 being FDA approved. I would be happy to use this product. Of course I would adhere to a gluten free diet but it would give me peace of mind when traveling and not having to constantly worry about ingesting gluten.

In response to SAS response: Do you have celiac disease? Do you know how hard it is to keep all gluten out of your diet? Like “Jane” said it “would give peace of mind” because sometimes it is accidentally ingested. A lot of products have gluten in them. Reading labels is very difficult and it is not always obvious as to whether something has gluten in it. The pill would not necessarily be a free pass to eating gluten. It would help people with celiac disease to heal and live a better, healthier life.

I was just telling my husband this morning that I would love to be able to travel with ease again. Thanks to Celiac, we rent houses, and I cook for the week before and freeze meals that are safe for me to eat. We maybe get to eat out twice depending on where we are vacationing. I would remain gluten free at home, but, oh, the joy at being able to eat without worry. Celiac isn’t the worst thing to have, but it would be lovely to be able to dine out easily while traveling. It would also be nice for my family not to be limited in choices thanks to my inferior peptides. Better living through chemistry!

Oh, happy day! I am a caterer with celiac and would love to be able to taste test my food products again. I rely on others to tell me if it’s too salt, sweet, or whatever. This way I could do it without the “reactions”. Not that I would go back to eating gluten, no way! But to know that I can tell my clients what things taste like would be pure joy!!

Gluten is harmful to most people and anyone with Celiac should stay far away from it if possible. Who knows what is in this drug? What food companies should do is stop putting gluten in everything and then people with Celiac would not have to take this pill. It’s ridiculous!

This would make my business lunches so much less awkward and travel much easier. I, like others, have to rent a house when vacationing and trying to eat in a restaurant is so much of a hassle that my husband and I just don’t bother. It would put my in laws at ease as well during holidays!

I look forward to having a drug that will help with the gluten you don’t see. So many times I buy things thinking they are gluten free but had to wonder later if they were not. It will also help me with the possible contamination issues when you have gluten eaters in your house and when eating out.

I like the idea of protection against accidental exposure. The one thing I miss most is Chicago pizza with a nice crispy chewy crust – wish there was something I could safely sprinkle on that. But then again, who needs the calories?

ModestinMN: Have you tried Against the Grain? Bar none the best GF pizza on the market. Its not Chicago style, but comes as close to that crispy chewy crust experience that I’ve found. Unfortunately I just learned I have to be DF as well as GF.

I second sixth the idea that this shouldn’t be viewed as a free ticket to eating gluten, but a safeguard against accidental contamination. As careful as we all are, it’s nearly impossible to know what’s cross contaminated. If only they could develop a gluten indicating tricorder-like device that you could wave over food…

Love the idea of protection against accidental glutening… but I am still hopeful for a “cure” as in I could go back to eating regular pizza and egg rolls and bean burritos at taco bell… I could go on and on… but seriously I hope this get’s approved!